The National Organization for Medicines (EOF) announced on Tuesday the recall of several batches of the thyroid medication Inacalcet produced by Pharmazac from the Greek market due to the possible presence of toxic substances.
The recall affects batches 2202370D and 2202370G for the 60 mg tablets, and batch 2202371D for the 90 mg tablets, following tests that found nitrosamine levels out of specification.
These batches are due to expire in June 2025.
According to the announcement, Pharmazac is obligated to notify pharmacists:
“Pharmazac SA, as the Marketing Authorization Holder of the product in Greece, must immediately contact the recipients and withdraw these specific batches from the market. Relevant documentation must be kept for at least five (5) years and provided to EOF upon request,” stated EOF.
In related news, EOF also announced the lifting of the recall for batches 4401620 (100MG/BTX1 PF.SYR+2N) and 4401617 (150MG/BTX1 PF.SYR+2N) of the drug DOPELIR – an antipsychotics medicine – INJ.SU.PRO, which were previously recalled due to an authenticity tape error but have now been repackaged.